Guidelines for Refractive Surgery Advertising
Statement of Purpose
These guidelines are designed to assist ophthalmologists in providing truthful, informative advertising of refractive surgery. In addition to their ethical obligations, ophthalmologists must be mindful of the legal obligations they have in connection with the promotion of their services.
These guidelines are not intended to address every possible advertising claim that could be made in support of refractive surgery. The guidelines address specific types of claims that could confuse consumers, and/or have been subject to Federal Trade Commission (FTC) review. Examples of permissible claims, as well as claims that might be considered to confuse or mislead consumers, are provided.
Legal Framework
The Federal Trade Commission Act, as well as similar state laws, prohibits false and deceptive advertising. Advertising that is literally true, but which conveys a misleading impression to reasonable consumers, may be unlawful. Claims made implicitly in advertising, as well as explicit claims, can give rise to deception. Deception also can occur through the omission of information if the absence of the information causes the advertisement to convey an inaccurate impression about a material fact. Thus, ophthalmologists should insure that statements made directly or by implication in informational, promotional, and advertising materials are accurate and do not deceive consumers.
One issue of current interest concerns the advertising of "off-label" surgical applications using a device approved by the Food and Drug Administration (FDA) (e.g. LASIK). [Editor’s note: LASIK is no longer "off-label."] The decision to use the excimer laser outside the scope of the approved labeling is considered, by the FDA, to be a "practice-of-medicine" issue; that is, the FDA has recognized that "Good medical practice and patient interests require that physicians use commercially available drugs, devices, and biologics according to their best knowledge and judgment." Physicians should be aware, however, that advertising of off-label use, while not specifically prohibited, is also not protected under the "practice of medicine."
Definition of Advertising: In addition to print, radio, and television ads, other material such as patient informational brochures, seminars, and videos may be considered advertising for purposes of these laws. Privileged discussions between physicians and their patients are generally not regulated by the FTC, but may have other legal or ethical implications. Although seminars and brochures may be considered advertising by the FTC, physicians do have a responsibility to adequately inform patients about alternative therapies.
Accountability: Physicians and other advertisers are legally responsible for the truth and accuracy of their advertising, even if it is prepared by an ad agency or other third party.
Substantiation: Medical advertisers, particularly with respect to surgical procedures, are held to a higher standard than those who advertise consumer products. The FTC requires that advertisers have a "reasonable basis" for advertising claims at the time they are made. With respect to health and safety claims for surgical procedures such as RK and PRK, this will usually require "competent and reliable" scientific evidence that may include, depending on the claim, the physician’s own outcomes alone or in combination with other clinical studies. Such clinical evidence is generally considered to be stronger if the study has been peer-reviewed and/or replicated in other studies. The advertiser must have adequate substantiation for a claim at the time the claim is made.
Informed consent: Advertising need not, and as a practical matter cannot, incorporate all of the elements of appropriate informed consent disclosures. FTC staff have stated that certain advertising claims may require disclosure of material information appearing in informed consent forms (see Safety Claims, Example 1). Also, advertising may not contradict disclosures of risk made in informed consent forms, and informed consent forms will not compensate, legally or ethically, for misleading statements made in advertising.
Testimonials: A patient endorsement or testimonial will be construed by the FTC as a representation that the particular patient’s experience is typical or representative of the experiences generally achieved by the physician’s patients, unless there is a clear and conspicuous disclosure to the contrary. In addition, physicians should be aware that some states prohibit the use of patient testimonials by physicians.
Advertising Claims
Prospective refractive surgery patients have differing needs and expectations and may experience differing surgical outcomes. Accordingly, advertising claims are not a substitute for discussions between the ophthalmic surgeon and a prospective surgery patient regarding the patient’s own needs and expectations and the range of possible outcomes.
Efficacy Claims
Example 1: Printed at the top of a newspaper ad is the banner: "Throw Away Your Glasses!" A reasonable consumer may infer from this ad that he or she will be permanently free of all forms of corrective lenses (for presbyopia and hyperopia as well as myopia) as a result of the surgery. Even if the ad makes reference to nearsightedness, there is a substantial risk that a significant number of consumers would infer from the ad that if they underwent the procedure, they would achieve 20/20 vision and would be free of glasses, including glasses for reading or occasional use. Since the surgeon cannot guarantee that the prospective patient would be permanently free from all glasses, the claim is subject to legal challenge.
Example 2: A print ad headline states, "Throw Away Your Glasses," or features a drawing of spectacles within a circle with a line crossed through it. Other text within the ad states that refractive surgery "may correct your nearsightedness and astigmatism and may eliminate your need for glasses or contacts." Although the use of the word "may" is intended to qualify the "no more glasses" claim, the claim is likely to be understood by consumers, in light of the more prominent headline or drawing, to be as unqualified as in Example 1. To avoid confusion, the overall message of an ad should not be inconsistent with the "fine print" qualifiers.
A further modification of the above claim, such as: "may correct your nearsightedness and astigmatism and may allow you to function without glasses or contacts for many activities," avoids possible ambiguities about the need for reading glasses or glasses for occasional use.
Example 3: A radio ad includes the text: "See naturally with refractive surgery!" The reasonable consumer would interpret "seeing naturally" or similar terms such as seeing clearly to mean "seeing without glasses." Again, this kind of claim should be avoided for the same reasons as for Examples 1 and 2, above.
Example 4: An ad picturing a smiling patient and physician states: "If you can read the small print, but can’t see well at a distance, visit Drs. Smith and Jones to learn more about RK (or PRK) — our typical nearsighted patient — after refractive surgery — no longer needs glasses for many activities." Such an ad is acceptable. It suggests that RK or PRK will treat only nearsightedness and informs consumers about the possible need for glasses for other activities.
Example 5: An ad states: "98% of our patients see 20/40 or better postoperatively — good enough to pass a driver’s test in most states!" Since the ad explicitly claims a result for a particular physician group’s patients, the physicians will need a study or analysis of patient records to substantiate the claim. In addition, this ad might be understood by some consumers to mean that since they can pass a driver’s vision exam, they might not need to wear glasses for other activities. This potential problem with the ad could be eliminated by a reference to the fact that patients may still need or desire glasses for some activities.
Safety Claims
Example 1: An ad states: "Find out more about PRK — the safe and easy alternative to glasses!" The terms "safe" and "safe and easy" have attracted the concern of the FTC, as have promotional materials that fail to disclose certain risks that may be considered to be important by a prospective patient. Generally, it is not appropriate for an ad to state that RK or PRK is safe and easy. Any ad that suggests that RK or PRK is safe should include a qualifying statement such as: "Like all surgery, RK (or PRK) surgery has some risks; we will discuss these with you during your consultation."
In addition, it is the position of the FTC staff that advertising containing certain claims may also need to contain relevant disclosures in order not to be considered deceptive. An FTC staff document relating to RK and PRK advertising expresses the following admonition: "representations made about safety or efficacy of RK or PRK may, in certain circumstances, require disclosures of material information about health risks or limitations associated with the surgery to prevent deception. For example, an advertisement containing express or implied representations that the surgery is safe may also need to contain information about any significant risks associated with the surgery, and for PRK, with the particular laser in use."
Example 2: A print ad states that, "unlike other procedures, PRK laser vision correction doesn’t involve knives or cuts to the eye." Although it is true that the Excimer laser does not use a blade to make incisions on the surface of the eye, the statement could be misleading to consumers by suggesting that PRK is a noninvasive procedure. It is not appropriate to claim or suggest, expressly or through use of euphemisms such as "treatment," "therapy," or "vision correction," or "enhancement," that RK or PRK are anything other than invasive surgical procedures.
While differentiation between refractive procedures may be appropriate in order to inform consumers, it should done in a way so as not to be misleading; both RK and PRK are surgical procedures, and this should be made clear to the reader of the ad.
Example 3: An ad states: "The Food and Drug Administration has Determined that the Excimer Laser We Use Is Safe and Effective for PRK Laser Surgery." Such an ad is not acceptable. The Federal Food, Drug and Cosmetic Act forbids references to the FDA-approval status of any medical device in advertisements.
Permanence and Predictability Claims
Example 1: An ad states: "Achieve permanent vision correction with refractive surgery!" A reasonable consumer may assume "permanent" to mean that their post-surgical refractive result will remain stable throughout their lifetime. FTC staff have raised questions with issues of the possibility of regression, drift, and possible instability long-term, and have objected to permanency claims because of their belief that studies of modern refractive surgery techniques available at the time of their review did not adequately substantiate such claims. At this time, physicians considering making claims of permanency or predictability should be aware that this advertising will be carefully scrutinized by the FTC. Accordingly, physicians should avoid permanency claims unless they are able to substantiate the claims on the basis of their own surgical outcomes alone or in combination with current scientific evidence.
Example 2: "Visit the Smith Laser Center and leave with 20/20 vision!" This ad is problematic. A reasonable consumer could interpret this advertisement to mean that the surgeon can guarantee, pre-operatively, exactly what the patient’s surgical outcome will be, i.e. that refractive surgery results are predictable. To advertise surgical predictability, physicians must be able to substantiate that surgical outcomes are predictable in virtually all of their cases.
The use of ranges, e.g. "80% of our patients have 20/20 vision following surgery," is acceptable if the surgeon can substantiate the claim.
Success Rate Claims
Example 1: "90% of RK (or PRK) patients achieve 20/40 vision or better." If this claim is based on a clinical study, the surgeon making the claim will need to assure that the study is scientifically reliable and that he or she is performing the same procedure using the same protocol as that involved in the study. If these criteria are met, the claim would be acceptable as long as the surgeon’s own outcomes did not vary significantly from the reported results.
Painless’ Claims
Example 1: An ad states: "PRK surgery is a safe and painless procedure." A reasonable consumer could understand this statement to mean that the entire experience — preparation, surgery, and recovery — is painless. Patients undergoing refractive surgery typically experience some pain and discomfort for a short time following surgery. Patients are often given prescriptions to deal with pain or discomfort. In these circumstances, "painless" claims are almost certain to be considered false or deceptive.
As with any other surgical procedure, new information and technology in refractive surgery can be expected to evolve over time. Accordingly, these guidelines are subject to periodic review and revision to ensure that they reflect the latest information and technology in refractive surgery.
These guidelines were developed and endorsed by: American Academy of Ophthalmology, San Francisco (Approved, Board of Trustees, February 1997); American Society of Cataract and Refractive Surgery, Fairfax, VA (Approved, Executive Committee, February 1997); International Society of Refractive Surgery in Altamonte Springs, FL (Approved, Board of Trustees, March 1997); Outpatient Ophthalmic Surgical Society, San Luis Obispo, CA (Approved, Board of Trustees, February 1997); and Society for Excellence in Eyecare in Washington, DC (Approved, Board of Trustees, February 1997).
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